• NS EN ISO 10993-1 : 2009 COR 2010

    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

    BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING

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    Withdrawn date:  15-01-2021

    Language(s): 

    Published date:  12-01-2013

    Publisher:  Norwegian Standards (Norges Standardiseringsforbund)

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    Table of Contents - (Show below) - (Hide below)

    Foreword
    Introduction
    1 Scope
    2 Terms and definitions
    3 General principles applying to biological evaluation
      of medical devices
    4 Categorization of medical devices
    5 Testing
    6 Selection of biological evaluation tests
    7 Assurance of test methods
    Annex A (informative) Rationale
    Annex B (informative) Flow chart to aid in ensuring a
            systematic approach to biological evaluation of
            medical devices
    Bibliography

    Abstract - (Show below) - (Hide below)

    Specifies general principles governing the biological evaluation of medical devices, categorization of devices based on the nature and duration of their contact with the body and the selection of appropriate tests.

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    Development Note Replaces NS ISO 10993-1:1994
    Document Type Standard
    Publisher Norwegian Standards (Norges Standardiseringsforbund)
    Status Withdrawn
    Superseded By
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